Probiotics for Girls With Recurring Urinary Tract Infections

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00789464
• Date of registration: 10/11/2008
• Prospective Registration: No
• Primary sponsor: Baylor College of Medicine
• Public title: Probiotics for Girls With Recurring Urinary Tract Infections
• Scientific title: H-23187: Probiotic Prophylaxis Against Recurrent Pediatric Urinary Tract Infection
• Date of first enrolment: November 2008
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT00789464
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: David R. Roth, MD
• Affiliation: Baylor College of Medicine

Key inclusion & exclusion criteria

Inclusion Criteria:

- Girls age 1 through age 17 years of age

- Must have had at least 3 symptomatic UTI, uncomplicated or complicated, in the year
preceding study inclusion or already using any form of prophylaxis to prevent
recurrences of UTI

- Must have had at least 3 symptomatic urinary tract infections in the year before the
start of the prophylaxis.

Exclusion Criteria:

- Breastfeeding

- Pregnancy

- Prior adverse reaction to sulfa drugs or sulfamethoxazole/trimethoprim

- Known immunosuppression i.e., transplant recipients or children with congenital
immunodeficiencies

- Poorly controlled diabetes

- Untreated HIV infection

- Use of high dose corticosteroids for autoimmune diseases or post-organ
transplantation. Inhaled corticosteroids or oral steroids for asthma are allowed.

- Malnutrition

- Patients with a history of sulfamethoxazole/trimethoprim-resistant UTI will be
excluded from the study

- Patients with renal insufficiency, liver insufficiency, or cardiopulmonary disease
requiring medication will be excluded from the study

- Patients with known anemia will be excluded from the study

- Patients taking medications that may interact with sulfamethoxazole/trimethoprim will
be excluded from the study

- Patients taking other probiotics will be excluded from the study

- Patients already taking prophylactic antibiotics will be excluded from the study



Age minimum: 3 Months
Age maximum: 17 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Recurrent Urinary Tract Infection

Intervention(s)

Drug: trimethoprim/sulfamethoxazole

Dietary Supplement: Lactobacillus reuteri DSM 17938

Primary Outcome(s)

The primary outcome will be the rates of bacteriuria among the subjects and the comparison of the two arms. [Time Frame: 1 year]

Secondary ID(s)

H-23187

Source(s) of Monetary Support

Please refer to primary and secondary sponsors